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A novel treatment approach to the management of asthma

Effective treatment management of asthma may require the use of two or three separate inhaler devices. But evidence reveals that people with asthma prefer simpler regimens, even if the pay-off is suboptimal control. This article examines a novel treatment approach and outlines the considerations and precautions that professionals and patients should take  

Sally Rose
RN BSc(Hons)
Asthma Nurse Specialist
Asthma UK

Although there is still no cure for asthma, most people with the condition can, and should, expect to live a full and active life that is not significantly limited by their symptoms.(1) But evidence suggests that many people with asthma accept suboptimal control as the "norm", resulting in unnecessary exacerbations, hospital admissions and limitations to their lifestyle.(2-4) Health professionals therefore have a responsibility to raise patients' expectations of attainable levels of symptom control. They must then meet those expectations by providing the resources, information and support that will allow people with asthma to be active participants in their own care. This principle is at the heart of government initiatives such as "Self Care Connect" and the "Expert Patient Programme".(5,6) If it is to become a reality in the lives of people with asthma, one of the resources they need is access to effective, user-friendly drug treatments.

Concordance
Asthma is characterised by symptom variability, and for people who have moderate-to-severe asthma, successful management of the condition may depend on following a complex, flexible treatment regimen. But evidence suggests that people with asthma want their treatment regimen to be as simple as possible, using the minimum number of inhaler devices and the lowest dose of inhaled corticosteroid (ICS) needed to treat their asthma - even if that means sacrificing a degree of symptom control.(7) To optimise concordance, prescribing health professionals must therefore be skilled in applying evidence-based pharmacological guidelines, while respecting each patient's beliefs and wishes about their asthma and its treatment.

The role of combination inhaler devices in asthma management
When asthma is not controlled at step 2 of the BTS/SIGN British Guideline on the Management of Asthma (see Resources), treatment should be stepped up by introducing an add-on therapy; a long-acting ß-2 agonist (LABA) is recommended as the first choice.(8) Patients may welcome this approach because it improves symptom control yet is steroid sparing. However, it presents a dilemma - whether to prescribe a separate LABA device in addition to the ICS and SABA devices, or to prescribe a combination inhaler (with ICS and LABA in one device). For example, the latter option is simpler for patients to use, but the former offers more flexible dosage options. Box 1 summarises some of the general "pros" and "cons" of combination inhalers.
The National Institute for Health and Clinical Excellence (NICE) has recently published its Health Technology Appraisal Corticosteroids for the Treatment of Chronic Asthma in Adults and Children Aged 12 Years and Over. It recommends that the choice of combination device versus separate ICS and LABA devices should be made on an individual basis, but, on balance, combination devices would normally be preferred.(9)

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There are currently three combination inhalers available:

  • Seretide [A&H] (ICS fluticasone/LABA salmeterol). Available as 100/250/500 Accuhaler or 50/125/250 Evohaler.(10)  
  • Symbicort [AstraZeneca] (ICS budesonide/LABA formoterol). Available as 100/6, 200/6, 400/12 Turbohaler.(10)
  • Fostair [Trinity-Chiesi] (ICS beclometasone/LABA formoterol); launched 2008. Available as 100/6 pressurised metered-dose inhaler.(11)

A new treatment approach
In 2007 a new treatment approach was launched that addressed some of the limitations of combination devices. It is delivered using one of the existing combination inhalers, Symbicort, and is called Symbicort Maintenance and Reliever Therapy (Symbicort SMART). It offers the potential to treat asthma at step 3 of the BTS/SIGN guideline with just one device.(12,13)

The evidence
Results from several studies and trials validate the safe, effective use of Symbicort SMART. A comprehensive list of references to these studies can be found on the pharmaceutical company's dedicated website.(14) Summarising these studies, the evidence shows that Symbicort SMART not only offers the usual advantages of a combination treatment (outlined in Box 1), but also provides the following benefits:

  • It can be used as a rapid-acting bronchodilator, replacing the need for a separate SABA. Formoterol has an onset effect comparable with the SABA, salbutamol, in both effectiveness and speed. (It's important to note that although Fostair also contains the LABA formoterol, the Fostair drug licence does not allow it to be prescribed in place of a SABA.)
  • It allows for a flexible dosing regimen, because both budesonide and formoterol are dose responsive, ie, higher doses have a greater effect, and it is safe to implement this within prescribed parameters.
  • It reduces the incidence of asthma exacerbations, resulting in fewer hospital admissions and reduced use of oral steroids.
  • It improves daily asthma control by reducing the incidence of asthma symptoms and the need for "as needed" reliever therapy.

How to use Symbicort SMART(12,13)
Patients who are prescribed Symbicort SMART should take maintenance doses in the traditional way (usually twice daily), but if symptoms are experienced in between, they should take an additional inhalation. This ensures that patients not only receive an
immediate perceived benefit of symptom relief through the rapid bronchodilating effect of formoterol, but they also receive a concurrent, extra dose of ICS budesonide to treat the underlying problem of increased inflammation in the airways. If symptoms persist a few minutes after an additional inhalation, another one should be taken. The maximum number of additional inhalations that can be taken in one episode is six.
If patients regularly need a daily total of more than eight inhalations, they should see their health professional for a full review of their asthma and a reassessment of their maintenance therapy. The maximum licensed daily dose of Symbicort SMART is 12 inhalations, which may be used for a limited time. However, if this level of treatment is required at any time, it is important that the patient sees their asthma nurse or doctor as soon as possible.

Who can take Symbicort SMART?
The drug is licensed for use in adults aged 18 years and over who are either controlled on step 3 or uncontrolled on step 2 of the BTS/SIGN guideline. It may be especially useful for patients who have poorly controlled asthma and frequently need a SABA, and for patients who have had asthma exacerbations in the past requiring medical intervention.(12,13)

Prescribing points
When prescribing Symbicort SMART, the following points should be noted:

  • It is not licensed for use as a prophylactic SABA, eg, prior to exercise, because of a lack of study data. A separate SABA should be prescribed for this purpose.(12,13)
  • Only Symbicort 100/6 and 200/6 are licensed for use as Symbicort SMART. Symbicort 400/12 is considered "inappropriate for 'as needed' use".(14)
  • Using the 200/6 strength as an example, and incorporating advice from the National electronic Library of Medicines (NeLM) and the Special Product Characteristics (SPC) literature, prescriptions for Symbicort SMART could be written as: "Symbicort 200/6 Turbohaler, one inhalation bd, plus as needed" or "budesonide 200 mcg/formoterol 6 mcg breath-actuated inhaler, one inhalation bd, plus as needed."(12,15)
  • Consider offering patients a referral to the NHS Direct Patient Support Programme. In this scheme, patients who are prescribed Symbicort SMART can give their consent to allow an NHS Direct healthcare adviser to provide telephone support for six to 12 months.(16) 

The place of Symbicort SMART in asthma management
This novel approach to asthma treatment throws up some interesting points for discussion and further debate. For example, although Symbicort SMART is broadly consistent with the stepwise treatment approach advocated in the BTS/SIGN guideline, it doesn't fit neatly into the defined "steps". This has two main implications. First, its place in clinical policies and guidelines will need defining, and those documents will need to be updated. Second, the approach doesn't translate very well to current templates for written personal asthma action plans (WPAAPs). Health professionals may therefore need additional time to write new, individual WPAAPs "from scratch"; the ones provided by the pharmaceutical company may not be sufficiently comprehensive.
 Another issue concerns the revised Patient Information Leaflet (PIL) for Symbicort 100/6 and 200/6. It is now more complicated, because it outlines both treatment options on the same PIL, ie, as a maintenance therapy only, and as a maintenance and reliever therapy.(17) This could be confusing for patients, because they all receive the same PIL regardless of which treatment approach they are following. Health professionals must be very clear about which option has been prescribed. It will need to be explained verbally, written into the patient's WPAAP, and recorded on their medical notes. The danger is that patients may switch to Symbicort SMART before discussion with their healthcare professional, resulting in the use of an unprescribed treatment that may not be appropriate for them.
A further issue to consider is the place of Symbicort SMART in current health promotion literature for people with asthma, their families and carers. For example, advice on what to do in an asthma attack can no longer be generic because reference to a "reliever inhaler that is usually blue" does not include Symbicort SMART. This has cost implications for organisations that provide asthma literature (such as Asthma UK) because their resources will need updating.
Additionally, organisations who deliver first aid training courses (such as the British Red Cross and St John Ambulance) need to be made aware that some people now use Symbicort SMART rather than a "blue inhaler" to treat an asthma attack. This information will need to be incorporated into first aid training courses and manuals.

Conclusion
Symbicort SMART is a useful new pharmacological approach to asthma management. There is a good chance that concordance will be good, because only one device is needed to fulfil three important functions of asthma treatment: to deliver rapid bronchodilation in response to symptoms; provide long-acting bronchodilator cover; and treat airways
inflammation.
The prescribing health professional must be aware of the limitations of Symbicort SMART, but for those adults in whom the regimen is appropriate, it offers the opportunity for effective yet simple asthma control, empowering people with asthma to be active partners in the management of their condition.

References

  1. Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention. Rev ed. 2006. Available from: http://www.ginasthma.org
  2. Asthma UK. The asthma divide - inequalities in emergency care for people with asthma in england. London: Asthma UK; 2007. Available from: http://www.asthma.org.uk/all_about_asthma/publications/the_asthma.html
  3. Asthma UK. Where do we stand? Asthma in the UK today. London: Asthma UK; 2004. Available from: http://www.asthma.org.uk/all_about_asthma/publications/where_do_we.html
  4. Partridge M, Molen T. Attitudes and actions of asthma patients on regular maintenance therapy. The INSPIRE study. BMC Pulm Med 2006;6:13.
  5. Self Care Connect: an NHS Working in Partnership Programme Initiative (WiPP). Available from: http://www.selfcareconnect.nhs.uk
  6. Department of Health. The expert patient: a new approach to chronic disease management for the 21st century. London: DH; 2001. Available from: http://www.dh.gov.uk/assetRoot/04/01/85/78/04018578.pdf
  7. Haughney J, Fletcher M, Wolfe S, et al. Features of asthma management: quantifying the patient perspective. BMC Pulm Med 2007;7:16. Available from: http://www.biomedcentral.com/1471-2466/7/16
  8. British Thoracic Society and Scottish Intercollegiate Guidelines Network. British guideline on the management of asthma. Rev ed 2007. Available from: http://www.brit-thoracic.org.uk/Portals/0/Clinical%20Information/Asthma/...
  9. NICE. Corticosteroids for the treatment of chronic asthma in adults and children aged 12 years and over. Technology appraisal March 2008. Available from: http://www.nice.org.uk/guidance/index.jsp?action=byID&o=11945
  10. Summary of Product Characteristics. Available from: http://emc.medicines.org.uk
  11. Electronic Medicicnes Compendium. Summary of product characteristics for Fostair. 2008. Available from: http://www.trinity-chiesi.co.uk/files/SmPC%20Fostair.pdf
  12. Electronic Medicicnes Compendium. Summary of product characteristics for Symbicort 100/6. Available from: http://emc.medicines.org.uk/emc/assets/c/html/displaydoc.asp?documentid=...
  13. Electronic Medicicnes Compendium. Summary of product characteristics for Symbicort 200/6. Available from: http://emc.medicines.org.uk/emc/assets/c/html/displaydoc.asp?documentid=...
  14. AstraZeneca. Symbicort® in asthma. Available from: http://www.symbicort.com/article/526120.aspx
  15. National electronic Library for Medicines (NeLM). SMART dosing regimen for Symbicort (budesonide/formoterol) Turbohaler launched in UK. 2007. Available from: http://www.nelm.nhs.uk/Record%20Viewing/vR.aspx?id=581566
  16. NHS Direct. NHS Direct launches new patient support programme. 2007. Available from: http://www.nhsdirect.nhs.uk/MediaObject.aspx?MediaObjectId=894
  17. Patient Information Leaflet (PIL). Symbicort Turbohaler 100/6 & 200/6 Inhalation Powder. Available from: http://xpil.medicines.org.uk/ViewPil.aspx?DocID=11050


Resources

Asthma UK
W: www.asthma.org.uk

Asthma UK Adviceline
T: 08457 01 02 03
Mon-Fri, 9am-5pm
BTS/SIGN British Guideline on the Management of Asthma - Revised Edition 2007
W: www.brit-thoracic.org.uk

SPC & PIL for Symbicort available from electronic Medicines Compendium (eMC)
W: www.emc.medicines.org.uk

Symbicort SMART
W: www.symbicort.com